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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71953-01
Device Problem Premature Discharge of Battery (1057)
Patient Problems Headache (1880); Hypoglycemia (1912); Convulsion/Seizure (4406)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported being unable to hear alarms on his freestyle libre 2 reader due to a fast draining battery.As a result, customer reported experiencing symptoms described as shoulder pain, "bites the tongue", headache, and seizure.Customer self-treated with food and glucagon and no further treatment was reported.There was no report of death or permanent injury associated with this event.
 
Event Description
Customer reported, being unable to hear alarms on his freestyle libre 2 reader, due to a fast draining battery.As a result, customer reported, experiencing symptoms described as shoulder pain, "bites the tongue", headache, and seizure.Customer self-treated with food and glucagon.And no further treatment was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint.And there was no indication, that the product did not meet specification.Dhrs (device history record) for the libre reader and kit pack were reviewed, and the dhrs showed the libre reader passed all tests prior to release.And correct cable was part of the kit pack.If product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
The reported reader (mamz122-j0429) was returned and investigated with retained test strips.Visual inspection was performed on the returned reader and a damaged usb port was observed.Reader did not power on with button depression, strip insertion, or insertion of usb cable.The damaged usb port prevented the customer from charging the reader, which led to the customer observing a blank screen when the battery died, therefore the complaint was not confirmed due to a use issue.No malfunction or product deficiency was identified.Section d3 (email) and section g1 were updated to reflect current contact information.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported being unable to hear alarms on his freestyle libre 2 reader due to a fast draining battery.As a result, customer reported experiencing symptoms described as shoulder pain, "bites the tongue", headache, and seizure.Customer self-treated with food and glucagon and no further treatment was reported.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE LIBRE 2
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key11066460
MDR Text Key223434037
Report Number2954323-2020-14361
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received12/28/2020
04/06/2021
Supplement Dates FDA Received01/14/2021
04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight74
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